Laparoscopic device

ABSTRACT

A medical instrument includes a tubular cutter extending along an axis and having a windowed outer sleeve and a moveable inner cutting sleeve. An ultrasound transducer is operatively coupled to the inner cutting sleeve in order to induce motion in the inner cutting sleeve to enhance cutting or resection of tissue by the inner cutting sleeve as it is reciprocated or otherwise moved past the cutting window. The instrument typically will include a motor drive configured to reciprocate and/or rotate the inner cutting sleeve relative to the windowed outer sleeve, usually at a reciprocation rate between 1 and 10 Hz.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/891,288, filed Oct. 15, 2013, the entire content of which isincorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates devices and methods for cutting andremoval of tissue from the interior of a patient's body, typically in alaparosopic procedure.

Laparoscopic and other minimally invasive tissue cutters are known, someof which operate by advancing a tubular blade past an open window in anouter housing to resect or sever intruding tissue. Optionally the cuttermay be rotated as it is axially advanced past the window to enhancecutting. Although quite effective, such cutters cannot always adequatelycut difficult tissue structure, and it would therefore be advantageousto provide improved devices and methods for laparoscopic and otherminimally invasive tissue resection,

2. Description of the Background Art

Reciprocating and rotational tissue cutters are described in U.S.Published Patent Applications 20130267937; 20130172870; and 20120330292.Atherectomy catheters having ultrasound imaging transducers on thecutting blades are described in U.S. Pat. No. 5,429,136.

SUMMARY OF THE INVENTION

In a first aspect, the present invention provides a medical instrumentcomprising a tubular cutter extending along an axis and having awindowed outer sleeve and a moveable inner cutting sleeve. An ultrasoundtransducer is operatively coupled to the inner cutting sleeve in orderto induce motion in the inner cutting sleeve to enhance cutting orresection of tissue by the inner cutting sleeve as it is reciprocated orotherwise moved past the cutting window. The instrument typically willinclude a motor drive configured to reciprocate and/or rotate the innercutting sleeve relative to the windowed outer sleeve, usually at areciprocation rate between 1 and 10 Hz.

The ultrasound transducer is typically configured to cause at least oneof axial motion and rotational motion in the distal end of the innercutting sleeve. Usually, the inner cutting sleeve will have a cuttingedge at is distal end so that the tissue may be effected by axiallyadvancing the blade in a distal direction. Rotational and/or oscillatorymotion may be superimposed on the axial reciprocation to enhance cuttingwith the ultrasonic motion being further superimposed to further enhancecutting. In other embodiments, the inner cutting sleeve may have anaxially oriented cutting edge so that cutting is provided primarily byrotation of the sleeve about the axis. In that case, axial oscillationmay be superimposed to enhance cutting together with the ultrasonicmotion. In all cases, a dimension between the ultrasound transducer andthe distal end of the inner sleeve may be selected to optimize at leastone of axial motion and rotational motion in the distal end of the innercutting sleeve.

In some embodiments, the instrument may further comprise at least asecond ultrasound transducer, wherein first and second ultrasoundtransducers are configured to cause axial and rotational motion in thedistal end of the inner sleeve. The ultrasound transducer may beremovably secured to a handle portion of the tubular cutter.

The instruments of the present invention may further comprise a negativepressure source coupled to a tissue extraction lumen in the tubularcutter. The instrument of the present invention may still furthercomprise a pressurized fluid source, either liquid, gas, or a mixedfluid, coupled to an inflow lumen in the cutter, and the inflow lumenmay extend to an outlet in a distal portion of the cutter.

The instruments of the present invention may further comprise acontroller coupled to the tubular cutter for controlling operatingparameters of the ultrasound transducer, the motor drive, the negativepressure source, and/or the pressurized fluid source. In such cases, theinstruments may still further comprise a sensor configured to sendsignals to the controller indicating the position of the inner sleeverelative to the window in the outer sleeve, and the controller may beadapted or configured to modulate activation of the ultrasoundtransducer in response to the sensor signals that indicate the positionof the inner sleeve. The controller may activate the ultrasoundtransducer when the inner sleeve moves toward a window-closed positionto cut tissue and de-activates the ultrasound transducer when the innersleeve moves toward a window-open position. In particular, thecontroller may activate the pressurized fluid source when the innersleeve is in a window-closed position and/or may de-activate thepressurized fluid source when the inner sleeve is in a window-openposition.

In a second aspect, the present invention provides a medical instrumentcomprising a tubular assembly extending along an axis with a windowedouter sleeve and a moveable inner cutting sleeve. The inner cuttingsleeve has a tissue-extraction passageway. A seal in thetissue-extraction passageway in the inner cutting sleeve has a firstcondition that closes the passageway and second condition that permits atissue chip to pass through the seal. The tubular assembly typically hasa flow channel terminating in a distal outlet in a region of theassembly that is distal to the seal, where the flow channel is incommunication with a fluid source or a negative pressure source.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic view of a tissue resecting device and blockdiagram of operating components corresponding to the invention in alaparoscopic resection procedure.

FIG. 2A is a cut-away view of a handle portion of a resecting device ofthe invention with a detachable ultrasound component de-coupled from thedevice.

FIG. 2B is a cut-away view of the resecting device handle as in FIG. 2Awith the ultrasound component coupled to the resecting device to providevibratory motion to the inner sleeve.

FIG. 3 is a perspective view of the ultrasound component de-coupled fromthe resecting device illustrating a plurality of piezoelectric elementscarried therein.

FIG. 4 is a perspective view of the working end of a shaft portion ofthe resecting device showing the assembly of the outer and innersleeves.

FIG. 5 is a perspective view of the working end of a resecting deviceshowing a sensor for sensing tissue contact.

FIG. 6 is a perspective view of another working end of a resectingdevice showing a plurality of sensors for sensing tissue contact.

FIG. 7 is a perspective view of another working end of a resectingdevice showing a rotating inner sleeve that can be coupled to anultrasound source.

FIG. 8A is a step of a method of cutting and extracting a tissue chip ina laparoscopic resection procedure using a tubular cutter as shown inFIGS. 1-4, with FIG. 8A being a sectional view of a resecting deviceworking end illustrating the activation of a negative pressure source tosuction tissue into a window of the cutter.

FIG. 8B is another step of the method following the step of FIG. 8Aillustrating the activation of motor drive to reciprocate the innercutting sleeve and actuating an ultrasound component to providevibratory motion at the inner sleeve edge to resect tissue drawn intothe window of the cutter.

FIG. 8C is another step following the step of FIG. 8B illustrating aresected tissue chip captured in an interior passageway of the cuttingsleeve.

FIG. 8D is another step depicting actuation of a pressurized fluid flowthrough an inflow channel and outward from a flow outlet distal to aninterior seal to eject the tissue chip through the seal in a proximaldirection in the interior passageway of the inner sleeve.

FIG. 8E is a further step after the pressurized fluid flow of FIG. 8Dpushes the tissue chip through the seal in the interior passageway.

FIG. 8F depicts a further step of the invention wherein anotherpressurized fluid flow outward from an outlet proximal of the seal topushes the tissue chip further in the proximal direction in the interiorpassageway.

FIG. 9 is a perspective view of another working end of a resectingdevice showing a plurality of seals in the tissue extraction lumen andflow outlets for providing independent fluid flows distal of each sealto assist in expelling tissue through each seal.

FIG. 10 is a perspective view of another resecting device working endshowing an independent fluid channel with a port proximate the window inthe outer sleeve for suctioning tissue into the window.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1, and 2A-2B illustrate a tissue resecting system 10 that includesa hand-held single-use tissue resection device 50. The device 50 has ahandle portion 102 that is coupled to a shaft portion 105 having anouter diameter ranging from about 3 mm to 20 mm. The shaft portion 105extends along axis 106 and can have a length suitable for introducingdirectly into a body space, for introducing though a trocar in alaparoscopic procedure or for introducing through a working channel ofan endo scope. A hand-held device corresponding to the invention asdepicted in FIGS. 1 and 2A-2B is adapted for laparoscopic resectionprocedures such as in a hysterectomy. FIG. 1 schematically illustratesthe tissue resecting device 50 introduced through a trocar sleeve orport 52 in a body wall 54 to an insufflated working space 55, which, forexample, can be an abdominal cavity. An endoscope 60 is introducedthrough a second port 62 to allow viewing of the tissue volume 65targeted for resection and extraction. An additional port can beprovided for a tissue grasping instrument (not shown) that may be usedin the resection procedure. In another embodiment, a similar elongateresecting device can be configured for resecting tissue in other bodytracts and spaces utilizing any type of endoscope to allow endoscopicviewing of the working space.

Referring to FIGS. 1, 2A-2B and 3, the resecting device 50 has a shaftportion 105 and working end 112 that comprises an assembly of a first orouter sleeve 115 extending along axis 106 to a distal end 116 having awindow 118 therein for receiving tissue. A second or inner sleeve 125with a distal blade edge 126 and distal opening 128 is dimensioned toreciprocate in bore 132 of outer sleeve 115. The outer and innersleeves, 115 and 125, are typically fabricated of thin-wall stainlesssteel but any other suitable materials can be used. As can be understoodfrom FIG. 4, reciprocation of the inner sleeve 125 will cut tissuecaptured in the window 118 of the outer sleeve. FIG. 4 shows the workingend 112 or the assembly of outer sleeve 115 and inner sleeve 125 withthe inner sleeve in a partially window-open position.

The resecting device 50 of FIGS. 1-2B includes subsystems operativelycoupled to handle 102 and inner sleeve 125 to enhance the cutting andremoval of tissue from a working space in the interior of a patient'sbody. FIG. 2A is a cut-away view of handle 102 of the resecting deviceshowing outer sleeve 115 fixed to collar portion 160 of the handle. Thehandle 102 typically consists of a molded plastic two-part handle shellwith a hollow interior. In one variation shown in FIGS. 1 and 2A, thereciprocatable inner sleeve 125 extends partly through the interior ofhandle 102 and has a proximal sleeve end 162 that is received in bore164 of cylindrical fixed member 165 that is fixed to support brackets172 in shell 144 of handle 102. As will be described below, the innersleeve 125 is reciprocated by DC electrical motor 148 in handle portion102 (see FIGS. 2A-2B).

In one embodiment, the DC motor 148 is housed within the handle withmotor shaft 185 having a pulley 186 that carries one or more flexiblebelts 188. The belts 188 can be fabricated of rubber, Viton® or asimilar material and are adapted to rotate the cylindrical drive member190 which in turn converts rotational motion to axial motion to therebyreciprocate the inner sleeve 125. A gear system instead of belts 188also can be used to rotate the drive member 190. The drive member 190 isrotatable and secured in the handle 102 at rotation-permitting collars192 a and 192 b at ends of the drive member. The inner sleeve 125extends through the drive member 190 and has a projecting first pin 194that engages the inner surfaces 195 of arcuate slot 196 in drive member190. The DC motor is geared (together with pulleys 186 and 198) torotate the drive member 190 at suitable speed to reciprocate the innersleeve 125 within a range of 1 Hz to 10 Hz. The DC motor 148 has anelectrical cable 202 extending to the controller 210 and a DC electricalsource 215.

Referring to FIGS. 2A, 2B and 3, the resecting device 10 may be part ofa system that includes a vibratory or ultrasound component 220 that isre-useable and removable from the resecting device 50. As can be seen inFIG. 3, the ultrasound component 220 has an elongate slot 222 thereinthat is configured to allow the component to slide axially overcylindrical fixed member 165 and the inner sleeve 125. Component 220carries a vibrating mechanism such as at least one piezoelectric element225 for applying vibratory motion to the inner sleeve 125 and moreparticularly to the distal blade edge 126 of the inner sleeve 125. Inone variation shown in FIGS. 2A-3, three piezoelectric elements 225 areshown. An electrical source 235 is coupled to the piezoelectric elements225 (see FIGS. 1 and 3) through electrical cable 236 and electricalleads (not shown) in the ultrasound component 220 to drive thepiezoelectric elements. As can be seen in FIGS. 2A-3, the ultrasoundcomponent 220 has a J-lock 242 that engages second pin 244 of the innersleeve 125 for securely locking the component 220 to the inner sleeve.The piezoelectric elements 225 are locked to inner sleeve 125 and areadapted to transmit energy to flange 238 of inner sleeve 125 and to itsdistal blade edge 126 (see FIGS. 2A-2B and 4). In one variation, thedimension between the piezoelectric element 225 and the distal bladeedge 126 (see FIG. 4) of inner sleeve 125 is selected to optimize motionin the blade edge. The dimension D relates to the length of a standingwave caused by the piezoelectric element in the material of sleeve 125as is known in that art of utilizing ultrasound to activate the workingend of medical instruments. It should be appreciated that any suitablelocking feature can be used to detachably couple the ultrasoundcomponent 220 to the inner sleeve 125 such as a threaded connector, aclamp, catches, magnets or the like. It should further be appreciatedthat independent electrical cable 236 that is directly coupled to theultrasound component 220 can be eliminated. Instead, the electricalpower for the ultrasound component 220 can be provided with electricalcable 202 and a slidable electrical contact (not shown) between handle102 and the ultrasound component 220 can deliver current to thepiezoelectric elements 225.

As can be seen in FIGS. 1, 2A-2B, and 4, the resecting device 10 may bepart of a system that includes a negative pressure source 240operatively coupled to a tissue extraction channel 252 in the devicewhich is in part the passageway in the inner sleeve 125. As can beunderstood from FIGS. 1 and 2A, a flexible outflow tube 254 can extendfrom the negative pressure source 240 to a quick-connect fitting 255 atthe end of the fixed member 165. The tissue extraction channel 252extends through inner sleeve 125 and handle 102 to the cylindrical fixedmember 165 (FIG. 2A). In one variation, the negative pressure source 240is a peristaltic pump but any other source such as hospital wall suctionmay be used. In another variation, the extraction channel 252 in thecombination of inner sleeve 125 and fixed member 165 can transition froma smaller cross-section to a larger cross-section to facilitate theextraction of cut tissue chips. The controller 210 is adapted to controlthe negative pressure source 240 as indicated in FIG. 1. A tissue catchstructure 258 is provided in outflow tube 254 to collect tissue chips.

In FIGS. 1, 2A-2B, and 4, it can be seen that the resecting device 10may be part of a system that includes a fluid source 260 that includespositive pressure mechanism for providing a pressurized fluid flowthrough an inflow lumen 265 in the resecting device shaft 105 which isused to assist in applying pressure to expel captured tissue chips fromthe instrument's working end 112. In one variation, the fluid source 260can comprise a reservoir containing saline solution and thepressurization mechanism can be a peristaltic pump. In anothervariation, the fluid source can be a hospital source of an insufflationgas such as CO₂. The fluid is delivered by tubing 268 to thequick-connect fitting 270 in handle 102. The flow pathway 272 in thequick-connect 270 extends through tubing 275 in the handle 102 to inflowlumen 265 in the shaft portion of the resecting device 50. As can beseen in FIG. 4, the inflow lumen 265 has a small cross section, e.g., adiameter from 0.05″ to 0.25″, and can be formed in the wall 276 of outersleeve 115 or can be provided in a hypotube affixed to the outer sleeve115. In one aspect of the invention, the inflow lumen 265 extends to anoutlet 277 that is proximate to or distal to the window 118 to allow afluid flow from the outlet in the window-closed position to applyproximally-directed fluid pressure on a tissue chip (not shown) capturedin the extraction channel 252. In one variation shown in FIG. 4, theinflow lumen 275 has a distal region 278 that includes a 180° turn toprovide a flow from outlet 277 that is aligned with the axis 106 of theshaft 105.

Referring to FIGS. 2A-2B, the system further includes a sensor 285 inthe handle that is adapted to determine the rotational position of drivemember 190 and to send a signal to the controller 200 that indicates thedrive member position. As can be easily understood from FIGS. 2A-2B and4, the rotational position of drive member 190 determines the axialposition of the inner sleeve and thus can indicate a fully window-openposition, a window-closed position or any intermediate window-openposition. In one embodiment, the sensor 285 is a Hall effect sensor thatis actuated when a magnet 288 in the drive member 190 passes the sensor.In another variation, the sensor can be a mechanically-actuated switchthat is actuated by an indent or projection carried by the drive member190. In other embodiments, any sensor known it the art can be used andthe sensor can be activated by either rotation of the drive member 190or axial movement of the inner sleeve 125 in the handle 102.

Referring back to FIG. 1, the controller 210 of system 10 is adapted toreceive signals from sensor 285 and in response can control operatingparameters of the ultrasound transducer, the negative pressure sourceand the pressurized fluid source in relation to a window-open orwindow-closed position of the cutter. In one embodiment, a footswitch290 is utilized to actuate the resecting device 50, but afinger-operated switch in the handle 102 also may be used (not shown).In one variation, the controller includes algorithms that activate thepiezoelectric element 225 only when the inner sleeve 125 is movingforward or in distal direction from the fully window-open position tothe window-closed position. In this variation, the piezoelectric element225 is de-activated on the return or proximal stroke from thewindow-closed position to the window-open position. Thus, the ultrasonicor vibratory effect at the blade edge 126 of the inner sleeve 125 isonly activated when tissue is being cut on the forward stroke of theinner sleeve.

Still referring to FIG. 1, the controller 210 can further control thepressurized fluid source 260 in response to signals from sensor 285 andthe window-open or window-closed position of the inner sleeve 125. Inone variation, the controller 210 has an algorithm that activates thefluid source 260 for a selected time interval only when the innercutting sleeve 125 is in a fully window-closed position. Thus, at themoment the inner cutting sleeve 125 cuts and captures a tissue chip inthe extraction channel 252, the controller 210 can provide a highpressure flow through the inflow lumen 275 and outlet 277 to push thetissue chip proximally in the extraction channel 252. In one embodiment,the controller 200 can have an algorithm that de-activates the motor 148to thereby stop reciprocation of inner sleeve 125 in the window-closedposition for a time interval to allow a longer pressurized flow from thefluid source 260 to push a captured tissue chip through the extractionlumen 252. For example, the inner sleeve 125 may be stopped for a timeinterval ranging from 0.1 second to 2 seconds.

Referring to FIG. 1, the controller 210 can include algorithms tomodulate the negative pressure source 240 in response to signals from asensor and the corresponding window-open or window-closed condition ofthe resecting device. In one variation of working end 112 shown in FIG.5, the at least one sensor 302 is provided proximate the window 118 tosense tissue contact with the window. For example, the sensor 302 can bea capacitance sensor that is configured to send a signal to thecontroller when the sensor contacts tissue. It can be easily understoodthat the capacitance reading from the sensor 302 when in contact withtissue would differ greatly from a capacitance reading in the absence oftissue contact. Any similar type sensor 302 could be used, such as animpedance sensor, pressure sensor and the like. As can be seen in FIG.6, another variation of working end 212′ can have a plurality of sensors302 and 304 and can be used to modulate the negative pressure source240. In one variation, the controller 210 can activate the negativepressure source 240 only when a sensor 302 and/or 304 (FIGS. 5 and 6) isin contact with tissue which then provides suction force to suctiontissue into the window 118. At other times, for example when thephysician is re-positioning the working end relative to tissue targetedfor resection, the negative pressure source 240 would be de-activated tothus prevent insufflation gas from being withdrawn from the workingspace 55 (see FIG. 1).

In another aspect of the invention, the controller 210 can include analgorithm adapted to move the inner cutting sleeve 125 to apredetermined position relative to the window 118 each time thephysician de-activates the device. In one variation, when the physicianlifts his or foot from the footswitch, or lifts finger from a trigger, a“stop-reciprocation” signal is sent to controller 210 which in turndetermines the location of the inner sleeve 125 relative to the window118 by means of a timer and the next signal (or previous signal) fromthe position sensor 285 that determines the rotational position of drivemember 190. The controller 210 then can calculate the time intervalneeded to stop the drive member 190 and sleeve 125 at a predeterminedlocation based on a library of known time intervals followingde-activation of the motor 148 to allow the inner sleeve 125 to coast(overcome momentum) to the predetermined position. In one embodiment,the predetermined position can be a fully window-open condition, whichwould then allow the physician to position the open window 118 againstthe targeted tissue to commence resection. In one variation, the edge ofwindow 118 and the tissue-contact sensor 302 would contact tissue whichthen cause the controller 210 to activate the negative pressure source240 to suction tissue into the window and also actuate reciprocation andthe piezoelectric elements 225. It should be appreciated that thecontroller algorithm may be programmed to activate the negative pressuresource 240 and reciprocation simultaneously or the reciprocation may beactuated in a sequence, for example 0.1 seconds to 2 seconds after thenegative pressure. Alternatively, the device may be provided with a twostage trigger, with a first trigger actuation movement activating thenegative pressure source and an additional second trigger movementactivating the reciprocation and piezoelectric element 225.

Referring back to FIGS. 3 and 4, it can be seen that the piezoelectricelements 225 are configured to cause axial motion in the distal end ofthe inner sleeve 125. In another variation, the piezoelectric elementscan be oriented to cause rotational motion in a keyed flange 138 (seeFIGS. 2A-2B) to rotationally vibrate the blade edge 126 of the innersleeve. In another variation, a plurality of piezoelectric elements canbe provided to cause both axial and rotational motion in the distal endof the inner sleeve. Such motion can be sequential or contemporaneous.The blade edge 126 can have any suitable configuration such as beingsmooth or having teeth, etc.

FIG. 7 illustrates another variation of a working end 405 correspondingto the invention in which an inner sleeve 410 is configured to rotaterelative to outer sleeve 415 rather that reciprocating as in theembodiment of FIGS. 1-5. It can be easily understood that a handlesimilar to that of FIG. 2A can use an appropriately geared motor torotate the inner sleeve 415 at a selected speed or rotate the sleeve 415sequentially in clockwise and counter-clockwise directions.Contemporaneously, the at least one piezoelectric element can be used tovibrate the inner sleeve 415 in the manner described previously. As canbe seen in FIG. 7, the window 418 of inner sleeve 415 has sharp teeth422 at its edge 424, and the combination of rotation and ultrasonic orvibratory movement of edge 424 will assist is cutting or sawing toughertissues. In one variation, the controller can include an algorithm thatwill sequentially rotate the inner sleeve from a window-open startposition in clockwise direction from 5° to 30°, then back past the startposition and then 5° to 30°, in a counter-clockwise direction followedby one or more increased sequential angular rotation to cut a tissuechip. After successive cutting by such sequential rotations, the innersleeve 415 can be rotated to the fully window closed position to capturethe tissue in the extraction lumen 440 of the inner sleeve. In onevariation, an inflow channel 265 as shown in FIG. 4 can be provided inthe device of FIG. 7 to allow proximally directed fluid flow to push thetissue chip in the proximal direction in the extraction channel.

In general, the controller 210 can control all operating parameters ofthe ultrasound component, the motor drive that reciprocates or rotatesthe inner sleeve, the negative pressure source and the pressurized fluidsource, as well as responding to signals from sensors to providesequential actuation of different component as well as to provideinterlocks between various operations and functions of the resectingdevices and systems of the present invention.

FIGS. 8A-8F illustrate another resecting device 500 of the inventionthat has a working end 512 including an outer sleeve 515 with window 518and a reciprocating, ultrasound-actuated inner cutting sleeve 525. Theresecting device 500 has at least one deformable seal 540 or valve inthe tissue extraction channel 544 which allows a cut tissue chip to passthru the seal 540. The seal 540 is configured to close to its reposestate to prevent the loss of insufflation gas after tissue passesthrough the seal. More in particular, FIGS. 8A-8F schematicallyillustrate one variation of resecting device 500 and a sequence ofoperating the pressurized fluid source 260 and the negative pressuresource 240 to assist in cutting and extraction of tissue chips in alaparoscopic procedure.

In FIG. 8A, the working end 512 of the resecting device is positioned sothat the window 518 is in contact with a targeted tissue volume 545. Asdescribed above, the controller 210 has algorithms that stop the innersleeve in a window-open position of FIG. 8A. At this point in time, noneof the operational mechanisms (ultrasound component, motor drive,negative pressure source and pressurized fluid source) are activated,thus no insufflation gas is lost though the device. The insufflationpressure is maintained automatically by an independent insufflatorsystem as is known in the art. In one variation, the physician thenpartially actuates a trigger switch 290 (see FIG. 1) which signals thecontroller 210 to activate the negative pressure source 240. In FIG. 8A,the negative pressure source thus suctions a portion of the targetedtissue 545 into the window 518. In FIG. 8B, the physician furtheractuates the trigger switch 290 which maintains activation of thenegative pressure source 240 and activates the motor 148 (FIG. 2B) tocause reciprocation of the inner sleeve 525 and simultaneously activatesthe ultrasound component. As can be seen in FIG. 8B, the distal movementof the inner sleeve 525 begins to cut tissue. FIG. 8C illustrates theinner sleeve 525 at the distal end of its stroke which captures a tissuechip 548 in the extraction channel 544 of the inner sleeve.

In FIG. 8D, the position of inner sleeve 525 at the distal end of itsstroke can cause a controller algorithm to optionally terminate theultrasound component and optionally halt reciprocation for a briefinterval as described above. With the inner sleeve 525 in the windowclosed position in FIG. 8D, the controller 210 causes the fluid source260 to provide a high pressure fluid flow through first inflow channel552 and outward from outlet 555 to thus push the tissue chip 548 throughthe seal 540 in extraction channel 544 as depicted in FIG. 8E. Thecontroller 210 can control the fluid volume, pressure and duration ofthe flow to optimize the expulsion of the tissue chip through the seal540. An instant after the fluid flow has applied proximally-directedforces to the tissue chip, FIG. 8E shows the controller has activatedthe motor 148 to thereby move the inner sleeve 525 to the window openposition.

FIG. 8F illustrates another step in the sequence of resecting tissuewherein the controller 210 causes the fluid source 260 to provideanother high pressure fluid flow through a second inflow channel 562 andoutward from outlet 565 to push tissue chip 548 further outward(proximally) through the extraction channel 544. It can be seen that theinflow channel 562 is within wall of outer sleeve 515 which has anoutlet 568 that is aligned with port 565 in the inner sleeve 525 to thuspermit a high pressure flow to reach the extraction channel 544 in theinner sleeve. In order to provide the fluid flows sequentially throughthe first inflow channel 552 and then the second inflow channel 562, thecontroller 210 can control solenoid valves 570 a and 570 b as shownschematically in FIGS. 8A-8F. Following the step of using the fluid flowto expel tissue as depicted in FIG. 8F, the sequence of steps 8A-8F canautomatically be repeated to rapidly resect the targeted tissue volume.It should be appreciated that the inner sleeve 525 may reciprocate at aconstant rate and the controller 210 can actuate the fluid source 260 atselected intervals to provide the sequential fluid flows through thefirst and second inflow channels 552 and 562. Further, the system can beconfigured to cause the pressurized fluid flow through the second inflowchannel 562 with the inner sleeve 525 in any axial position relative towindow 518.

In another variation, referring to FIG. 9, the inner sleeve 525 may beconfigured with a plurality of seals, for example seals 540 and 540′with inflow ports 565 and 565′ (which can be elongated slots) to allowfor a plurality of flow pulses in different axial locations to push andexpel tissue chips through the extraction channel 544. The flow pulsescan be contemporaneous or sequential through inflow ports 565 and 565′from a single inflow channel 562 and outlets 568 and 568′ or can besequenced through a plurality of independent inflow channels each incommunication with an inflow ports 565 and 565′. In various embodiments,the number of seals 540 and corresponding inflow ports 565 can rangefrom 1 to 10.

In any embodiment, the passageway seal 540 can be any type of flexibleleaflet-type seal, hinged-door seal, duckbill-type seal or the like thatis adapted to close the passageway in a repose condition.

FIG. 10 illustrates another resecting device 570 that is similar to thatof FIGS. 8A-8F except that outer sleeve 515 carries an independentpassageway 575 coupled to negative pressure source 240 that iscontrolled independently by controller 210 to provide suction forces inthe interior of window 518. More in particular, the independentpassageway 575 in outer sleeve 515 extends to a distal opening 577 in adistal region of the bore 580 of sleeve 515 proximate window 518. Thus,the controller 210 can actuates the negative pressure source 240 tosuction tissue into the window independent of suction force providedthrough the tissue extraction channel 544 of the inner sleeve 525.Further, the controller 210 can use an algorithm to modulate suctionpressure through passageway 575 and opening 577 during differentportions of the stroke of the inner sleeve 515 to optimize suction forpulling tissue into the window and to minimize loss of insufflation gas.The controller 210 can operate solenoid valves 590 a and 590 b tocontrol negative pressure in the channels 544 and 575. In one variation,the inner sleeve 515 can have a slot or notch 585 that is axiallyaligned with opening 577 so that the opening is not covered by the innersleeve 515 during a distal region of the sleeve's reciprocation. Thus,suction forces can be applied to tissue throughout reciprocation of theinner sleeve 515.

In the various embodiments described above, the inflows from fluidsource have been described as any suitable fluid or flow media. Itshould be appreciated the flow media can be a liquid (e.g., saline orsorbital) or a gas such as CO₂. Either a liquid or gas can be used toassist in expelling tissue, with each having its advantages. The use ofa incompressible liquid could apply greater expelling forces to acaptured tissue chip. The use of an insufflation gas can reduce thecomplexity of the system. In a variation, the system could use a gasmedia to expel a just-cut tissue chip from the region of the windowthrough the seal 540 in the step shown in FIG. 8D and then use a liquidflow in the step depicted in FIG. 8F. In such a variation, pulse liquidflows can operate continuously or intermittently during operation of thedevice.

It should be appreciated that the features described in the systemembodiments of FIGS. 8A-10 including seals 540 and independent suctionpassageway 570 can be provided in a “rotating” inner cutting sleeve asillustrated in FIG. 7.

In another variation, a plurality of piezoelectric element can each becoupled to a separate elongated member or component that is a part of anassembly that comprises the reciprocating or rotating cutting sleeve.Thus each piezoelectric element can drive a member that has a selectedlength to cooperate with a standing wave in the material caused by thepiezoelectric element to optimize the tissue effect at the distal end ofthe cutting sleeve. Each elongated member can have an axial or spiralconfiguration.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

What is claimed is:
 1. A medical instrument comprising: a tubular cutterextending along an axis and having a windowed outer sleeve and amoveable inner cutting sleeve; a first ultrasound transducer operativelycoupled to the inner cutting sleeve; and at least a second ultrasoundtransducer, wherein first and second ultrasound transducers areconfigured to cause axial and rotational motion in the distal end of theinner sleeve.
 2. The instrument of claim 1 further comprising a motordrive configured to reciprocate the inner cutting sleeve relative to thewindowed outer sleeve.
 3. The instrument of claim 2 wherein the motordrive reciprocates the inner cutting sleeve at a reciprocation ratebetween 1 and 10 Hz.
 4. The instrument of claim 1 wherein the ultrasoundtransducer is configured to cause at least one of axial motion androtational motion in the distal end of the inner cutting sleeve.
 5. Theinstrument of claim 4 wherein a dimension between the ultrasoundtransducer and the distal end of the inner sleeve is selected tooptimize at least one of axial motion and rotational motion in thedistal end of the inner cutting sleeve.
 6. The instrument of claim 1wherein the ultrasound transducer is removably secured to a handleportion of the tubular cutter.
 7. The instrument of claim 1 furthercomprising a negative pressure source coupled to a tissue extractionlumen in the tubular cutter.
 8. The instrument of claim 7 furthercomprising a pressurized fluid source coupled to an inflow lumen in thecutter.
 9. The instrument of claim 8 wherein the inflow lumen extends toan outlet in a distal portion of the cutter.
 10. The instrument of claim8 wherein the pressurized fluid source comprises a liquid source. 11.The instrument of claim 8 wherein the pressurized fluid source comprisesa gas source.
 12. The instrument of claim 7 further comprising acontroller coupled to cutter for controlling operating parameters of theultrasound transducer, the motor drive, the negative pressure source andthe pressurized fluid source.
 13. The instrument of claim 12 furthercomprising a sensor configured to send signals to the controllerindicating the position of the inner sleeve relative to the window inthe outer sleeve.
 14. The instrument of claim 13 wherein the controlleris adapted to modulate activation of the ultrasound transducer inresponse to the sensor signals that indicate the position of the innersleeve.
 15. The instrument of claim 14 wherein the controller activatesthe ultrasound transducer when the inner sleeve moves toward awindow-closed position to cut tissue and de-activates the ultrasoundtransducer when the inner sleeve moves toward a window-open position.16. The instrument of claim 13 wherein the controller activates thepressurized fluid source when the inner sleeve is in a window-closedposition.
 17. The instrument of claim 13 wherein the controllerde-activates the pressurized fluid source when the inner sleeve is in awindow-open position.
 18. A medical instrument comprising: a tubularassembly extending along an axis with a windowed outer sleeve and amoveable inner cutting sleeve, wherein the inner cutting sleeve has atissue-extraction passageway; and a seal in the tissue-extractionpassageway in the inner cutting sleeve, the seal having a firstcondition that closes the passageway and a second condition that isconfigured to permit a tissue chip to pass through the seal.
 19. Theinstrument of claim 18 wherein the tubular assembly has a flow channelterminating in a distal outlet in a region of the assembly that isdistal to the seal, wherein the flow channel is in communication with afluid source.
 20. The instrument of claim 18 wherein the tubularassembly has a flow channel terminating in a distal outlet in a regionof the assembly that is distal to the seal, wherein the flow channel isin communication with a negative pressure source.
 21. A medicalinstrument comprising: a tubular cutter extending along an axis andhaving a windowed outer sleeve and a moveable inner cutting sleeve; anultrasound transducer operatively coupled to the inner cutting sleeve; anegative pressure source coupled to a tissue extraction lumen in thetubular cutter; a pressurized fluid source coupled to an inflow lumen inthe cutter; a motor drive configured to reciprocate the inner cuttingsleeve relative to the windowed outer sleeve; a controller coupled tothe tubular cutter for controlling operating parameters of theultrasound transducer, the motor drive, the negative pressure source,and the pressurized fluid source; and a sensor configured to sendsignals to the controller indicating the position of the inner sleeverelative to the window in the outer sleeve; wherein the controller isadapted to modulate activation of the ultrasound transducer in responseto the sensor signals that indicate the position of the inner sleeve.